NCT06226987

Brief Summary

Better methods for early detection of cardiac involvement in Fabry disease are needed to inform clinical management decisions that can help prevent or slow the progression of cardiac complications. In the Molecular Imaging of Inflammation in Fabry Disease of the Heart study, the investigators will test the use of 68Ga-DOTATATE PET/MRI for identifying myocardial inflammation in patients with Fabry disease.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2026

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

January 17, 2024

Last Update Submit

July 18, 2024

Conditions

Fabry Disease, Cardiac Variant

Outcome Measures

Primary Outcomes (2)

  • PET imaging vs. oedema detected by MRI

    Concordance between 68Ga-DOTATATE PET signal and myocardial oedema on MRI assessed by T2-weighted imaging

    Baseline

  • PET imaging vs. fibrosis detected by MRI

    Concordance between 68Ga-DOTATATE PET signal and myocardial fibrosis detected by late gadolinium enhancement MRI

    Baseline

Study Arms (1)

Fabry Disease with cardiac involvement

Diagnostic Test: 68Ga-DOTATATE PET/MRI

Interventions

68Ga-DOTATATE PET/MRIDIAGNOSTIC_TEST

PET/MRI scanning

Fabry Disease with cardiac involvement

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants with cardiac involvement in Fabry disease assessed by MRI

You may qualify if:

  • Male or female participants \>18 years old
  • Able to give written, informed consent and to lie flat
  • Have Fabry disease based on molecular diagnosis (at a minimum, documented enzyme deficiency in males and documented pathogenic mutation in females)
  • Cardiac MRI within 3 years documenting cardiac involvement in Fabry disease (left ventricular hypertrophy and/or late gadolinium enhancement and/or myocardial oedema)

You may not qualify if:

  • Any other diagnosis associated with cardiac muscle inflammation, including myocarditis
  • Previous gene therapy
  • Contra-indication to MRI scanning or intravenous gadolinium contrast (prior contrast reaction or chronic kidney disease with eGFR \<30 mL/min/1.73 m2)
  • Women of child bearing potential not using adequate contraception
  • Uncontrolled atrial fibrillation
  • Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Related Publications (2)

  • Tarkin JM, Joshi FR, Evans NR, Chowdhury MM, Figg NL, Shah AV, Starks LT, Martin-Garrido A, Manavaki R, Yu E, Kuc RE, Grassi L, Kreuzhuber R, Kostadima MA, Frontini M, Kirkpatrick PJ, Coughlin PA, Gopalan D, Fryer TD, Buscombe JR, Groves AM, Ouwehand WH, Bennett MR, Warburton EA, Davenport AP, Rudd JH. Detection of Atherosclerotic Inflammation by 68Ga-DOTATATE PET Compared to [18F]FDG PET Imaging. J Am Coll Cardiol. 2017 Apr 11;69(14):1774-1791. doi: 10.1016/j.jacc.2017.01.060.

    PMID: 28385306RESULT

  • Corovic A, Wall C, Nus M, Gopalan D, Huang Y, Imaz M, Zulcinski M, Peverelli M, Uryga A, Lambert J, Bressan D, Maughan RT, Pericleous C, Dubash S, Jordan N, Jayne DR, Hoole SP, Calvert PA, Dean AF, Rassl D, Barwick T, Iles M, Frontini M, Hannon G, Manavaki R, Fryer TD, Aloj L, Graves MJ, Gilbert FJ, Dweck MR, Newby DE, Fayad ZA, Reynolds G, Morgan AW, Aboagye EO, Davenport AP, Jorgensen HF, Mallat Z, Bennett MR, Peters JE, Rudd JHF, Mason JC, Tarkin JM. Somatostatin Receptor PET/MR Imaging of Inflammation in Patients With Large Vessel Vasculitis and Atherosclerosis. J Am Coll Cardiol. 2023 Jan 31;81(4):336-354. doi: 10.1016/j.jacc.2022.10.034.

    PMID: 36697134RESULT

MeSH Terms

Conditions

Fabry Disease, Cardiac Variant

Central Study Contacts

Jason M Tarkin, PhD MBBS

CONTACT

+44(0)1223331504jt545@cam.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Wellcome Clinical Research Career Development Fellow & Honorary Consultant Cardiologist

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 26, 2024

Study Start

January 2, 2024

Primary Completion

January 2, 2026

Study Completion

January 2, 2026

Last Updated

July 22, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)